A Phase 3, Multicentre, Double-masked, Randomised Study to Evaluate the Efficacy and Safety of Intravitreal OPT-302 in Combination with Aflibercept, Compared with Aflibercept Alone, in Participants with Neovascular Age-related Macular Degeneration (nAMD)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 990
- 试验地点
- 3
- 主要终点
- Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
研究概览
简要总结
This study is a Phase 3, multicentre, randomised, parallel-group, sham-controlled, double-masked, superiority study of approximately 102 weeks in duration. Eligible study participants will be randomised at Baseline to one of three treatment arms in a 1:1:1 ratio: intravitreal aflibercept followed by Standard Dosing 2.0 mg OPT-302; intravitreal aflibercept followed by Extended Dosing 2.0 mg OPT-302; or intravitreal aflibercept followed by a sham injection. The study has two phases, the Efficacy Phase (Baseline to Week 52 [Visit 15]) and the Safety Phase (Week 52 to Week 100 [Visit 15 to Visit 27]). Although efficacy and safety will be assessed during both study phases, the efficacy of OPT-302 is intended to be characterised during the Efficacy Phase (via the primary and secondary efficacy endpoints), and the safety of OPT-302 after long term (2 year) administration is intended to be characterised during the Safety Phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •â€¢Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
- •â€¢An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
- •Main Exclusion Criteria: •Any previous treatment for neovascular AMD.
- •â€¢Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
- •â€¢Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
排除标准
- •â€¢Active subfoveal CNV lesion or juxtafoveal CNV lesion with foveal involvement that is secondary to AMD in the Study Eye.
- •â€¢An ETDRS BCVA score between 60 and 25 (inclusive) letters in the Study Eye.
- •Main Exclusion Criteria: •Any previous treatment for neovascular AMD.
- •â€¢Clinically significant ocular disorders (other than neovascular AMD), which may interfere with assessment of BCVA, assessment of safety, or fundus imaging.
- •â€¢Any current (or history of a) social, psychological, or medical condition that precludes enrolment into the study.
结局指标
主要结局
Mean change in Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters
时间窗: Baseline to Week 52
次要结局
- 1.Proportion of participants gaining 10 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters 2.Proportion of participants gaining 15 or more Early Treatment Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA) letters 3.Proportion of participants with absence of both sub-retinal fluid (SRF) and intra-retinal (IR) cysts by spectral domain optical coherence tomography (SD-OCT) 4.Change in choroidal neovascularisation (CNV) area by fluorescein angiography (FA) 5.Change in central subfield thickness (CST) by spectral domain optical coherence tomography (SD-OCT) 6.Change in National Eye Institute 25-question visual function questionnaire (NEI VFQ-25) composite score Change in mean composite score of 25 questions. A higher mean change means an overall improvement in visual function.